Culturally adapted Family Intervention (CaFI) for African-Caribbean people diagnosed with schizophrenia and their families: a mixed-methods feasibility study of development, implementation and acceptability

Schizophrenia and psychoses

Schizophrenia is a syndrome of psychotic disorders. Psychoses/psychotic disorders are severe mental illnesses (SMIs) characterised by delusions, hallucinations, changes in behaviour and related problems of cognition, thoughts and emotions. In their 2012 systematic review, Kirkbride et al. 1 reported the pooled annual incidence of psychotic disorders as 32 cases per 100,000 and of schizophrenia as 15 per 100,000.

Although the incidence of psychotic disorders was once believed to be similar across all populations, Kirkbride et al. ’s1 findings confirm those of studies in the last decade,2–7 indicating that rates of psychoses among Black and minority ethnic (BME) populations are significantly higher than in comparison populations among whom they reside. Overall, evidence suggests that rates of schizophrenia are 5.6 times greater in Black Caribbean people than in White British people [95% confidence interval (CI) 3.4 to 9.2]. Elevated rates were also reported in Black African [relative risk (RR) 4.7, 95% CI 3.3 to 6.8; I² = 0.47] and Asian groups (RR 2.4, 95% CI 1.3 to 4.5; I² = 0.42). The Aetiology and Epidemiology of Schizophrenia and Other Psychoses study8 of populations in London, Bristol and Nottingham reported even higher incidence rates among African-Caribbean people (71/100,000 per year). This equates to a risk of diagnosis that is ninefold higher than in the White British population (incidence rate ratio 9.1, 95% CI 6.6 to 12.6).

Schizophrenia and related psychoses are associated with considerable personal, economic and societal burdens. It is estimated that the total annual cost of a broadly defined schizophrenia (non-affective psychoses) is £8.8B. 1 Forty per cent (£3.5B) of this cost is attributable to service use, 47% (£4.1B) to lost employment and 13% to informal care (£1.2B). Although it is not entirely clear why some BME groups are at greater risk of psychosis, it is suggested that ‘urbanicity’, discrimination and socioeconomic disadvantage are important contributory factors. 9,10

African-Caribbean people, schizophrenia and UK mental health services

African-Caribbean people’s elevated risk in the UK is accompanied by poorer utilisation of services and worse clinical and non-clinical outcomes, especially among young men. 2,3,11,12 African-Caribbean people’s experience of specialist mental health services is also poor. 6,13–15 Characterised by delayed access, despite multiple attempts at help-seeking, their care pathways are more adverse than those of their White British counterparts. 15 For example, they are less likely to access specialist services via general practitioners and more likely to do so via the police and criminal justice system,15–17 with high rates of detention under the Mental Health Act 2007. 18 African-Caribbean family members disproportionately report involving the police because they are unable to gain timely access to support from specialist services. 19 This is important because delayed access to diagnosis and treatment increases the duration of untreated symptoms and the illness acuity on contact with services. 20,21

Once in specialist services, African-Caribbean people experience more coercive care than White British people, including higher rates of seclusion and restraint, plus higher mean doses of psychotropic medication and related side effects. 13,15 They are also less likely to be offered psychological therapy, and they experience worse clinical outcomes, such as longer inpatient stay and higher rates of relapse and readmission. 8,13 The Centre for Mental Health22 described African-Caribbean people’s experience of mental health services as a vicious ‘circle of fear’ involving delayed engagement/non-engagement, adverse care pathways, coercive treatment and inferior outcomes. These experiences, combined with perceptions of services as institutionally racist, reinforce African-Caribbean service users’ and families’ fear, mistrust and avoidance of statutory mental health services. 14,22–24 Delayed access to care also creates considerable family tension, conflict and increased burden on carers, which can result in family breakdown. Lack of access to family support and social contact is, in turn, associated with service users’ social isolation and increased risk of relapse. 25

Family intervention and schizophrenia

Family intervention (FI) is a psychosocial treatment with a strong evidence base of clinical effectiveness. 26,27 Since the findings from the first UK trial of FI for schizophrenia were published in 1982, research has consistently shown that undertaking FI with service users diagnosed with schizophrenia and their families improves outcomes. 9,27–30 For example, in their Cochrane review, Pharaoh et al. 26 reported that FI improved medication compliance, self-management and problem-solving, which were associated with reduced risk of psychotic relapse. In a meta-analysis of randomised controlled trials (RCTs),27 FI plus medication yielded better outcomes than medication alone. In addition to decreasing or preventing relapse, improving service users’ social functioning and enhancing their quality of life, a key aim of FI is to reduce carer burden and ill-health. 31

Although there are a number of approaches to FI, they share common core components such as psychoeducation, problem-solving, stress and crisis management, enabling carers to practise good self-care. 26,27 The core principles of FI models include a holistic approach to care and treatment, establishing therapeutic alliance, addressing family tension and setting reasonable and achievable goals and expectations. The National Institute for Health and Care Excellence (NICE)30 recommends at least 10 sessions of FI for people with schizophrenia diagnoses who are in contact with their families. Few services provide FI for the general population. 32 At a time of significant financial pressures on the NHS and related reduction in staff numbers, perceptions of FI as time and labour intensive and, therefore, costly, mean that FI practitioners are rarely given time to practise. 33

Family intervention and African-Caribbean people

Commenting on care providers’ inconsistent and ineffective response to inequalities in the care and the treatment of African-Caribbean people diagnosed with schizophrenia, NICE11 specifically recommends FI for African-Caribbean people with schizophrenia. The unavailability of FI might disproportionately affect BME service users in general, as they are known to have inferior access to psychological therapies. 15 African-Caribbean service users are likely to have even poorer access to FI owing to high levels of family disruption.

In community consultation to develop this study, African-Caribbean people expressed dissatisfaction with the lack of access to psychological therapy and expressed a strong desire for culturally appropriate ‘talking treatments’. They also wanted to develop better understanding of schizophrenia and improve relationships within families, between African-Caribbean communities and with mental health services.

However, lack of research into the feasibility of delivering psychological therapies in general, and FI in particular, to African-Caribbean people means that it is unclear if the benefits of FI are generalisable to members of this ethnic group. 26 Furthermore, it is unclear if a standard approach to the content and delivery of FI would be acceptable to service users and families whose relationship with mental health services and health-care professionals is characterised by a lack of trust.

In response to concerns and dissatisfaction within African-Caribbean communities, and in response to NICE guidelines,11 we undertook to culturally adapt an evidence-based, cognitive–behavioural model of FI, which was developed by co-applicants Barrowclough and Tarrier. 34 This model was selected because previous work by the principal investigator (PI)35,36 and others37,38 has suggested that African-Caribbean people’s models of mental illness and related attributions require cognitive–behavioural interventions such as FI to be culturally adapted for this group. Additionally, the evidence-based model was developed and is the model of choice in Manchester Mental Health and Social Care NHS Trust (MHSCT), where the study was conducted.

Research questions

1. How can existing evidence-based FI be culturally adapted for African-Caribbean people with schizophrenia and related disorders?

2. Is it feasible for culturally adapted FI to be delivered in hospital and community settings?

3. Can ‘proxy families’ serve as acceptable alternatives where families are unavailable?

4. Will culturally adapted FI be acceptable to service users, families and health professionals?

Aims and objectives

Phase 1: culturally adapting the intervention

The purpose of this phase of the study was to identify the elements of the existing FI model to be culturally adapted, determine how such modifications would be achieved, identify and agree on suitable outcome measures and identify training needs associated with delivery of the intervention. This aspect of the study was conducted in the following three subphases.

Phase 2: training

The purpose of the training phase was to recruit and train therapists and FSMs to undertake their role in CaFI, ensuring that we addressed the training needs identified during phase 1 of the study. Underpinned by outcomes from phase 1, we worked with our service users and carers and Just Psychology,44 a Manchester-based social enterprise that specialises in cultural diversity, to develop bespoke cultural competency training for CaFI therapists, co-therapists and FSMs. We also employed Meriden Family Programme45 to deliver bespoke training on culturally specific family work for the therapists. In line with NICE recommendations, to deliver cultural competence training at both organisational and individual levels, we planned to deliver competency sessions in a range of clinical settings, reflecting areas of recruitment into our study. However, organisational issues meant that this was not possible. Instead, we delivered a trust-wide clinical seminar for all staff and delivered presentations to promote the study and cultural awareness among clinical leads, health-care professionals, and service user and carer groups in the NHS and in third-sector organisations.

Phase 3: feasibility study

What does involvement in CaFI mean?

Having the active involvement of service users, carers/relatives and members of the public was to improve the quality, governance, feasibility and practicality of our research by:

• including the perspective of African-Caribbean people in the development, management and oversight of the project

• ensuring that cultural competency training included service user, carer and community member perspectives

• ensuring that recruitment and consent processes were appropriate for service users and families (family members and ‘FSMs’)

• ensuring that our communication with the families and ‘FSMs’ was accessible and acceptable

• discussing and agreeing suitable forms of dissemination with service users and families, drawing on their knowledge and expertise to identify and access suitable outlets.

CaFI Research Advisory Group

The purpose of CaFI’s RAG was to maximise the involvement of service users, carers, families and members of the community in our research. Our RAG panel consists of eight people of African-Caribbean background (six women and two men) who are passionate about making a difference to the lives of African-Caribbean people living with mental health problems in their local community and across the UK.

Research Advisory Group meetings were held (two or three times per year; eight meetings in total) during the 3 years and were chaired by a co-applicant, Paul Grey, who has lived experience and expert knowledge in the area. As a former Delivering Race Equality in Mental Health Care Ambassador, Paul has a wealth of experience delivering seminars and conferences and advising policy-makers and service providers on the mental health of BME communities and their experience of services. He also has > 20 years’ experience of using mental health services.

The RAG advised and supported the team in developing research materials [such as the participant information sheet (PIS) and adverts], as well as advising on appropriate recruitment and dissemination strategies. The RAG also helped to refine the therapy manual, in particular the ‘ethos of delivery’, and co-produced and delivered the training programmes during phase 2. They also participated in the dissemination of our work through conference presentations.

Community launch events

To generate awareness and engage the local community, we hosted two community-level launch events in areas of high population density of African-Caribbean people, both within the MHSCT footprint in South Manchester [Levenshulme Inspire Community Centre (25 October 2013) and Moss Side Leisure Centre (30 October 2013)]. During the events, the PI and research project manager (RPM) delivered presentations to:

1. outline the study’s rationale, aims and objectives

2. highlight opportunities to get involved, including becoming RAG members and FSMs

3. gauge the level of interest and willingness among eligible individuals; we provided food and drink as we know this to be important for socialising and building relationships in African-Caribbean cultures. 48

Altogether, the events were attended by around 100 people, including community members, service representatives, service users, carers, family members, and health and social care professionals. Anecdotal feedback from attendees was extremely positive and many were keen to get involved and support the research, as participants, advisors or collaborators. The majority of attendees left their details so that they could be contacted for further information. Following the event, the RPM was invited to present the CaFI study at third-sector organisations and to host a stall at the African & Caribbean Mental Health Services (ACMHS) Mental Health and Well-being Day (18 October 2013), to further promote the study. The event provided a platform for us to strengthen collaborations with Black-majority churches, community groups and agencies, including the ACMHS, Just Psychology,44 Manchester BME Network,49 Black Health Agency,50 Manchester Carers Forum,51 ReThink: Manchester Carers in Action,52 Self-Help Services,53 Service User Voices54 and Bluesci. 55

Phase 1 research question

How can existing evidence-based FI be culturally adapted for African-Caribbean people with schizophrenia and related disorders?

Search strategy

On 3 March 2016, the RPM conducted an electronic database search of Ovid MEDLINE, EMBASE, PsycINFO and Web of Science. Databases were searched from inception and no date or language restrictions were specified (see Appendix 1 for the full search strategy and search terms). The titles and abstracts were downloaded into EndNote X8 Management software (version 8; Clarivate Analytics, Philadelphia, PA, USA) and duplicates were removed. The RPM (AD) and research assistant (RA) (SB) independently screened the articles for eligibility using the following inclusion and exclusion criteria.

Inclusion and exclusion criteria

Selection of studies

Full-text papers of potentially relevant articles were accessed and screened by the RPM (AD) and RA (SB). Authors were contacted with requests for English versions of non-English citations and citations that could not be accessed. Interlibrary loans were also sought for inaccessible papers. Reference lists of full-text articles and systematic literature reviews were screened to identify any additional papers not picked up in the search. Key experts were contacted and received the full reference lists to identify any missing studies. All uncertainties or disagreements relating to the eligibility of articles were resolved via discussion with a co-applicant and senior researcher (RD).

Data extraction

Descriptive characteristics of eligible studies were recorded in a data extraction spreadsheet. To address the research question regarding the nature of cultural adaptations, all adaptations to interventions described in the papers were summarised in a second spreadsheet. When there was limited information, corresponding authors were contacted and adaptations were extracted from any additional literature or notes provided by the authors.

Data synthesis

A thematic analysis59 was used to evaluate the nature of cultural adaptations across the reviewed studies. A number of frameworks have been developed to provide guidance on cultural adaptations to treatments67,69,72,73,75 and two of these have been applied to data in recent reviews. 61,68 The thematic analysis was applied inductively to the extracted data to generate themes and subthemes of adaptations emerging from their current application in the field, rather than to deductively apply an existing model to the data.

Included studies

The database search returned 4695 results, providing 3723 unique citations after duplicates were removed. Titles and abstracts were screened and a further 3405 articles were excluded. Full texts of the remaining 318 articles identified as potentially relevant were accessed and examined against the eligibility criteria. Of these, 32 were included in the review. An additional 14 articles were identified for inclusion through e-mailing authors and searching reference lists of the full-text papers. The study selection process is presented in the PRISMA flow diagram shown in Figure 1.

FIGURE 1.

The PRISMA flow diagram. CINAHL, Cumulative Index to Nursing and Allied Health Literature.

Study characteristics

In total, 46 papers reporting 43 individual trials with 7828 participants were included. The characteristics of the reviewed studies are detailed in Appendix 2. Studies comprised 31 RCTs, 12 cluster RCTs, two non-randomised pilot studies and one block RCT. The mean age of service users ranged between 24 and 57 years and, among the studies that reported gender (n = 38), 42% were female. Sample sizes varied across the studies, ranging from six76 to 3082,77 with a mean of 182. All studies included samples of service users who had a diagnosis of schizophrenia spectrum disorder, usually defined using DSM-IV and ICD-10 screening criteria.

Three RCT papers included participants who had been reported in an earlier paper: one paper78 reported 24-month follow-up data of a subsample of an earlier RCT;77 one study79 used the same sample as an earlier paper;80 and one three-armed RCT81 included a subsample of participants reported in an earlier two-armed RCT. 82 Of the 39 studies reporting attrition, the range was from zero83–85 to 43.4%. 86 Attrition was < 15% in 25 studies83–85,87–108 and > 40% in three studies. 86,109,110 Attrition was not reported in seven studies. 71,76,87,111–114

Intervention characteristics

The characteristics of the culturally adapted psychosocial interventions assessed in the reviewed studies are described in Appendix 3. Interventions were delivered in 13 countries. The majority (74%, n = 34) were conducted in Asia (25 in China,77–80,83,84,87,89,94,96–98,100–102,104–110,113–115 two in each of Pakistan,71,92 Taiwan, Province of China,88,116 and India86,112 and one in each of Iran,91 Saudi Arabia76 and Malaysia93). Nine studies (20%) were conducted in the Americas (six in the USA,81,82,85,99,117,118 two in Mexico119,120 and one in Brazil95), and one study (2%) was conducted in each of Italy,90 Australia1 and Egypt. 111 Most interventions (85%, n = 39) were adapted for a majority non-Western population and seven studies (15%) were adapted for a minority population.

Around half of the studies (54%, n = 25) were FIs consisting of a psychoeducational or mutual support component. FIs varied across the studies in terms of their components and the evidence-based models from which they were adapted (see Appendix 3). The majority (88%, n = 2277–80,83–87,89–91,94,98,100,101,104,105,114,115,117,118) involved group family therapy sessions; only three FIs93,96,97 consisted of just individual sessions. In 12 of the FIs studies (48%),80,83,84,87,89,94,98,101,104,105,115,117 all of the sessions were designed for the family members and service users to attend together. In five studies, service users attended at least part of the intervention (25–86% of the sessions) and in the remaining eight studies77–79,85,86,90,91,114 only family members were invited. Ten (22%) studies evaluated some form of cognitive therapy, consisting of three social cognitive skills training,81,82,102 one social cognitive remediation therapy,111 three CBTs,71,92,107 two metacognitive training110,112 and one integrated psychological therapy (IPT). 95 Family members attended two71,121 of the CBT interventions; the remaining eight81,82,95,102,110–112,122 cognitive interventions were for service users only. Three studies73,109,113 were combined interventions comprising components adapted from multiple Western therapy manuals and theoretical frameworks; two of these were symptom-coping programmes and one included family therapy sessions. Five studies99,106,108,119,120 assessed social skills training (SST). Family members attended four of the SST interventions. Of the remaining interventions, two were illness management and recovery (IMR) programmes88,116 and one was a mindfulness-based psychoeducation programme,103 both of which were for service users only.

The majority of interventions (59%, n = 2771,79,80,82–86,88,91,92,94,96–98,101,103–105,107–109,111–113,116,119) were delivered in clinical settings. Six interventions81,90,99,106,114,117 were delivered in community settings and four87,89,93,115 delivered sessions in both clinical and community settings. Nine studies did not report intervention setting. 76–78,95,102,106,110,118,120 The duration of interventions ranged from 3 weeks88 to 2 years,77,78,89,90 with a mean of 8 months. The majority of the interventions were led by mental health professionals (80%, n = 37); five of these (all assessing group FIs) were co-facilitated by a family member participating in the study. Five studies did not specify therapist training (see Appendix 3).

Cultural adaptations of interventions

Phase 1 study objectives

1. Involve key stakeholders (service users, families and clinicians) in culturally adapting an existing FI for African-Caribbean people with schizophrenia (phases 1B and 1C).

2. Produce a manual to support delivery of the intervention (phase 1C).

3. Identify client and family centred outcomes and quality-of-life outcomes (phases 1B and 1C).

4. Identify therapist and FSM training needs (phases 1B and 1C).

Study design

This was a cross-sectional qualitative cohort study using focus group methodology with key stakeholders. We conducted three separate stakeholder focus groups for service users, carers and advocates, and health professionals. We convened a purposefully selected ‘mixed’ group (comprising stakeholders from the initial focus groups) to verify emergent themes and agree the items to be taken to the consensus conference (phase 1C), where final decisions about CaFI’s content, delivery and associated training were made.

Participants and recruitment procedures

We used novel recruitment strategies building on the PI’s community engagement work at community mental health conferences and with service users (at the request of our service users, this term is used in preference to ‘patient’ throughout the report) and Patient and Public Involvement (PPI) events supported by National Institute for Health Research’s (NIHR’s) Research Design Service’s bursary award. Potential participants were recruited via events in accessible venues, such as churches and community centres. Information was also posted in community newspapers and the Manchester Evening News and the study was presented during live phone-in discussions about mental health and illness on local radio stations instigated by the PI. The PI and RPM made presentations to service user and carer forums, Community Mental Health Teams (CMHTs) and voluntary sector organisations, including our collaborating partner ACMHS. Advertisement posters/flyers (see Appendix 6 for service user example) were also placed strategically at various community locations and sites within the host NHS trust (MHSCT). Recruitment information was also made available via the ‘Get Involved’ page of the Researching African Caribbean Health website [URL: http://research.bmh.manchester.ac.uk/ReACH/getinvolved (accessed 2 December 2017)], which we created for this study.

Procedures and materials

Interested individuals who contacted the research team were provided with PISs (see Appendix 7 for service user example), tailored for each stakeholder group and given at least 48 hours to decide whether or not to opt into the study. Potential participants met with the RPM to address any queries and complete consent forms (see Appendix 8 for service user example).

Reflecting the differing perspectives of the stakeholder groups, separate topic guides (see Appendix 9 for service user example) were developed for each focus group based on the literature review (phase 1A) and information generated in discussions with former service users and carers when developing the study. Topic guides and supporting materials were refined via consultation with our RAG.

Each focus group commenced with context setting and establishing ground rules to help create a ‘safe space’ for individuals to talk about potentially sensitive and/or distressing experiences in relation to schizophrenia and mental health care, and to ensure that all participants were afforded the opportunity for their voices to be heard.

Demographic information (age, gender, ethnicity, marital and employment status, postcode and religion) were collected and consent regarding recording and data usage confirmed. Strategies for dealing with distress were also outlined and sources of available support provided (see Appendix 10). All focus groups were facilitated by the PI, supported by the RPM.

Data collection

Data analysis

The data were transcribed, checked for accuracy, and identifying material was removed and analysed using framework analysis42 by the RPM and PI, with input from the wider team and qualitative methods experts independent of the team. Framework analysis is a systematic process of data analysis that allows for inclusion of both a priori and emergent themes and concepts. 128,129 A framework approach was particularly suited to our study as there were specific topics we wanted to explore, such as the content and delivery of the intervention, as well as ascertaining participants’ views about key issues, such as the utility of the intervention and recommendations for maximising uptake.

The interconnected stages of framework analysis include familiarisation (through the reading and re-reading of the transcripts), coding, framework development, charting and indexing. This was used to guide data analysis from initial management through to the development of explanatory accounts. Data verification strategies included peer and participant review to examine and verify themes, findings and conclusions. For example, two other experienced qualitative researchers (Baker and a qualitative methods specialist independent of the research team), rigorously reviewed the research process and emergent findings identified by the PI and RPM. In addition, findings were shared with the wider research team and Research Management Group (RMG). The ‘mixed’ focus group served as a means of ‘member checking’ or ‘respondent validation’, were participants were given the opportunity to comment on the validity of findings. These are recognised methods of ensuring ‘trustworthiness’ of the data and subsequent findings. 130,131 NVivo version 10 (QSR International, Warrington, UK) was used to support data management and analysis.

Theme 1: content of the intervention

Participants did not suggest that any of the current FI content (outlined in Box 2) was irrelevant. Instead, they suggested additional African-Caribbean-specific elements (summarised below) in relation to the different components of FI.

Problem-solving and goal-planning

The extant FI model outlines 10 steps that the service user, family and therapist work through to solve problems and achieve agreed goals. These were presented to focus group members using a visual representation created by the CaFI team to explain the process (Figure 2).

FIGURE 2.

Worked example of problem-solving and goal-planning.

Participants thought that this was helpful: they liked breaking goals into small, achievable steps, solution-focused approaches and focusing on progress versus failure; and creating opportunities to celebrate even small successes was especially welcomed. They believed that this approach could have a significant influence on family conflict resolution and confidence building in African-Caribbean families:

I think what this does is really kind of gets the family to realise, and also the service user, how resourceful they are to find a solution to their problem . . . So, in one way, it develops confidence that ‘I have got the resources’.

Male carer

I think also if it does break down at any point I think it would be useful to focus on how far you’ve travelled and the positive rather than the negative . . . you’ve got so far round that circle and that’s a very positive step and if you focus on that, then maybe next time you’ll get past that place and on to the next stage.

Female carer

Although participants liked the process, their responses highlighted the need to develop a range of culturally appropriate tools to support delivery of the intervention. For example, although some participants liked the visual representation (see Figure 2), others suggested that it could be interpreted as ‘going round in circles’ and that perhaps a more linear representation might suit some families (the availability of resources for supporting delivery is explored further in Theme 3: delivery of CaFI):

. . . as a flow chart and that does work because then you do exactly what you’re saying, you do feel like you’ve got to the end and the solution is at the end.

Female health-care professional

Theme 2: desired outcomes and measures

In our original application, we identified (from existing literature) outcome measures to be feasibility tested during the trial (phase 3). Mindful that some of these measures might lack cultural specificity and the reported service experiences of this ethnic group, we gave stakeholders the opportunity to (a) identify the most relevant service user and family-centred outcomes and (b) agree the primary and secondary outcome measures that they considered most relevant for a future RCT of CaFI.

We shared copies of potential measures with participants and sought their opinions about which were most relevant to African-Caribbean people.

Participants expressed concerns about the number of measures, the length of some and the cultural appropriateness of all. There was agreement that outcomes were an important aspect of testing any intervention.

Increased knowledge was regarded as particularly beneficial for families and carers because ‘knowledge is power’ (female carer). Participants suggested that more culturally appropriate tools were needed and endorsed our decision to update the Knowledge About Psychosis Interview (KAPI),133 itself derived from Barrowclough and Tarrier’s Knowledge About Schizophrenia Interview (KASI). 34,134 Although the KAPI is used in the current study, we have validated a new Knowledge About Psychosis (KAP) measure and developed and validated a culturally adapted version specifically for African-Caribbean people (Culturally-adapted Knowledge about Psychosis; CaKAP) for use in future trials (paper under review).

Other desired family outcomes included:

• better attitude towards wellness and recovery

• improved stress management and coping

• feeling more supported

• having better access to resources (both NHS and community level).

Desired service user outcomes included:

• developing better family relationships (e.g. better attitude, less perceived criticism)

• measurable changes that might indicate moving towards recovery such as:

  • reduction in symptoms

  • less reliance on medication

  • fewer hospital admissions:Female health-care professional

    I suppose what we could measure would be things like less admission to hospital and less reliance on medication [agreement].

Participants also spoke about potentially negative or harmful outcomes to avoid, such as a breakdown in trust between families and therapists, and carers feeling less supported. Accordingly, measures to assess therapeutic alliance were endorsed. A breakdown in family relations that leads to service users’ alienation from their families and increased isolation was regarded especially negatively:

I suppose becoming more alienated from your family, [agreement] that’s got to be one that you want to avoid but it might actually be as a result of the family therapy.

Female health-care professional

It was agreed that all measures should be accessible (using visual representations vs. written information where possible), and should be capable of collecting data longitudinally to evaluate CaFI’s impact over time and in other contexts:

. . . there needs to be some way of evaluating it and seeing what works and what can be changed, because you could be asked to deliver it in London next year or something, you never know.

Female service user

These discussions culminated in the decision to take a number of measures to the Consensus Conference for a final decision about the measurement of CaFI outcomes (see Chapter 6, Methods).

Theme 3: delivery of CaFI

We invited participants to comment on what, if anything, needed to be done to ensure that the delivery of CaFI was culturally appropriate for African-Caribbean people. Stakeholders’ views were also sought on key issues to support the delivery of CaFI, including the training needs of therapists and ‘proxy families’. Three subthemes emerged from respondents’ views on the delivery of CaFI: (1) ‘ethos of delivery’, (2) ‘therapists’ knowledge and skills’ and (3) ‘practical issues’.

Participant recruitment

Despite ongoing debate about the expertise of experts,144 defining participants by expertise remains an essential feature of consensus methods. 43 A cohort of local, regional and national experts (n = 24) was identified using a range of approaches.

Academics were recruited based on their track record of conducting and publishing national and international research pertaining to African-Caribbean people with schizophrenia and cultural adaptation.

Current and former service users who regarded themselves as being from African-Caribbean backgrounds (‘Black British’ and ‘mixed’ heritage) were recruited from the University of Manchester’s Service User Research Group, ACMHS, MHSCT and service user forums.

Carers and advocates were recruited from a number of Manchester carer forums and third-sector organisations. To ensure as broad a range of consensus as possible, we also recruited members of voice hearing networks and the ‘antipsychiatry’ movement.

Health professionals were identified by their expertise in working with BME groups in general and African-Caribbean people in particular. We specifically involved individuals with expertise in FI.

Police representation was provided by contacting Greater Manchester Police.

Procedures and materials

Interested individuals were provided with the PIS (see Appendix 14) and met with the RPM to determine eligibility, discuss their involvement and address any queries. Individuals were given at least 48 hours to make a decision about their participation before meeting with the RPM to sign a consent form (see Appendix 8 for service user example).

A full-day consensus conference was co-facilitated by the PI, RPM and co-applicant (JB) at the University of Manchester.

The day was divided into three sessions reflecting the emergent themes from focus groups (phase 1B). Accompanying discussions focused on the cultural specificity of the proposed intervention to agree:

1. content

2. outcome

3. delivery.

Findings from phases 1A and 1B were presented to the consensus panel using PowerPoint presentations (see Appendix 15), which also outlined:

• the rationale for the study

• the overview of the work conducted to date (phases 1A and 1B)

• the purpose and structure of the consensus conference

• an explanation of how ‘consensus’ would be determined.

Turning Point (version 5.3.1., Turning Technologies, Belfast, UK), an interactive audience response system, was used to facilitate data collection. Embedded within the PowerPoint slides, the easy-to-use polling software enabled participants to respond to questions using their handsets (‘clickers’), generating ‘real-time’ data. ‘Real-time’ voting and analysis was chosen in preference to other consensus methods such as the Delphi, which can lack transparency and is comparably slower. 145 As votes were instantly translated into on-screen graphs, they were viewed by participants and used to generate further discussion and resolution when needed (e.g. when ranked items received the same score).

Reflecting our co-production approach, the views of ‘experts by experience’ (service users, carers and the community) were considered as important as expertise by professional standing. 144 Each expert had one vote per item. All votes were considered equal and no individual had a casting vote. Voting ceased when all experts had voted.

Data collection

The findings from the focus groups were presented to the experts for consideration of the extent to which the proposed adaptations would improve the cultural specificity of FI for African-Caribbean people. For each aspect of the intervention, experts were shown the current content of FI alongside the additional elements focus group members identified as key to improving its cultural specificity (see Chapter 3). Consensus was reached via two methods: (1) discussion and (2) subsequent voting.

Participants

The final sample comprised 22 experts (24 were recruited but two were unable to attend on the day). Participants included ‘experts by experience’ [services users and carers (n = 5); carers and advocates (n = 9), including the third sector and church] and ‘experts by profession’ [(n = 7) including academics, police, health professionals and service managers with expertise in schizophrenia in the African-Caribbean population].

Cultural specificity

Table 1 shows that experts achieved near-unanimous consensus (between 81% and 95%) that all items generated by the focus groups and the literature would improve the cultural specificity of CaFI for African-Caribbean people: specifically, its content, outcome and delivery.

Content

Psychoeducation

This aspect of FI generated the greatest number of recommended additional items from the focus groups (eight in total). Items considered especially relevant for African-Caribbean people included:

1. better understanding of how the mental health ‘system’ works

2. information about rights in relation to police involvement

3. effects of stigma (within families, communities and wider society)

4. challenging stereotypes and misconceptions

5. understanding psychotropic medication – how it works, side effects

6. understanding the relationship with illicit drug use and medication/illness progression

7. culturally specific models of mental illness

8. better awareness of available resources (community and NHS).

Experts ranked these items numerically so that those ranked more important were assigned higher numbers. The cumulative value of rankings for each of the content areas is represented in Figure 3 by the weighted count. Figure 3 shows that items were ranked fairly evenly, with ‘how the “system” works’ (15%), ‘models of illness’ (15%) and ‘medication’ (14%) rated the top three most important aspects of psychoeducation in CaFI. Illicit drug use (8%) was ranked lowest.

FIGURE 3.

Ranked importance of additional ‘psychoeducation’ content.

Focus group members indicated a strong dislike of the term ‘psychoeducation’. Experts chose ‘shared learning’ (Figure 4) from the available options (6 out of 21 voters, 29%). As ‘mental (ill) health awareness’ was voted a close second (5 out of 21 voters, 24%), further discussion ensued from which shared learning received the most votes by a show of hands (n = 15).

FIGURE 4.

Votes for preferred alternatives to psychoeducation.

Outcomes

Focus group members identified 10 desired outcomes. For CaFI, the top five outcomes were ranked as ‘better familial relationships’, ‘health and well-being’, ‘social functioning’, ‘reduction in relapse and readmission’ and ‘relatives’ positive attributions and attitudes towards illness’. As shown in Figure 5, several of the outcomes had similar weighted counts, indicating that most were deemed important by experts. This is reflected in this quote from one expert about the difficulty of ranking inter-related items:

I’m a bit torn between ‘social functioning’ . . . and also ‘coping with stress’ because I think with these topics some of them go hand-in-hand. But I think coping with stress is fundamental to staying well and hopefully not becoming unwell again, not being readmitted and also with activity and how you’re doing on a day-to-day basis so I don’t know which one’s [to rank] one and two really.

FIGURE 5.

Ranked importance of potential outcomes from the CaFI.

‘Knowledge about schizophrenia’ received the lowest ranking. Although some experts felt that this was an important outcome to measure, others disagreed:

The problem that I have with this is that it implies that if you rank something 10 or whatever it implies that you have fairly neutral feelings about it. I would actually positively object to knowledge about schizophrenia being an outcome measure in a study like this . . .

Following further discussion, experts agreed that in future studies, to examine CaFI’s effectiveness, ‘reduction in relapse and readmission’ should be a primary outcome and ‘relatives’ attributions and attitudes’ a secondary outcome. Interestingly, although originally ranked last, ‘knowledge about schizophrenia’ was agreed to be an important outcome that should be considered, with the proviso that a culturally valid version would be developed.

Delivery

In the final consensus conference session, experts were tasked with agreeing:

• how best to adapt the delivery (vs. content) of FI to ensure that it suited the needs of African-Caribbean people

• key approaches to supporting delivery of the intervention

• training needs of therapists and ‘proxy family’ members.

Experts agreed that these three objectives were inextricably linked. Consequently, much of their discussion focused on CaFI’s ‘ethos of delivery’ and therapists’ ability to establish and maintain therapeutic relationships with members of this community in the context of a history of fear and mistrust of services.

Phase 2 study objective

To address the training needs of therapists and FSMs identified during phases 1B (focus groups) (Box 9) and 1C (expert consensus conference) (Box 10).

Training content

Supervision

All therapists received hourly supervision fortnightly with lead and co-therapist pairs by the same supervisor who was a member of the RMG and was involved in the development of the therapy manual and therapist training in the manual. The supervisor was a clinical psychologist, accredited CBT therapist and experienced trial therapist in psychological therapy for SMI and in the supervision of psychological therapists in the NHS. A significant part of supervision focused on adherence to the model and manual. The research team (PI, RPM and clinical supervisor) also facilitated two group supervision sessions for therapists to share good practice and to discuss and problem-solve common issues/barriers relating to delivering the sessions.

First wave of recruitment

We recruited three therapist dyads [lead therapist (NHS Agenda for Change band 7) and co-therapists (NHS band 4)] to deliver up to 300 hours of therapy to 30 families (30 × 10-hourly sessions) across acute, rehab and community settings over a 12-month intervention period. Our original proposal was to recruit clinical psychologists as lead therapists. Unable to do so within our host NHS trust, we recruited lead therapists with experience of family work within the trust, comprising one social worker and two OTs working in CMHTs and rehabilitation units. Each had undertaken training in a CBT-based model of FI which we had culturally adapted through training in advanced psychosocial interventions for psychosis. Co-therapists comprised two support workers and an assistant psychologist, all working in CMHTs. Therapists delivered CaFI as part of their current caseload at MHSCT, thus allowing us to explore the feasibility of embedding CaFI within the mainstream services.

Second wave of recruitment

The host trust, MHSCT, underwent considerable financial and service upheaval during the study, which affected the job roles and workloads of a significant number of staff. By the end of the study, MHSCT had merged with Greater Manchester West NHS Foundation Trust (GMW) to form Greater Manchester Mental Health NHS Foundation Trust.

Although it had been agreed with managers that therapists would be released for one clinical session per week (4 hours/half-day) to undertake the CaFI work, this proved to be difficult. In practice, therapists were attempting to deliver CaFI alongside their caseload due to staff pressures. They reported lacking the capacity to manage an increased caseload and deliver the 10 CaFI sessions within the agreed therapy window of 20 weeks.

Having successfully recruited service users and families to the feasibility trial (phase 3; see Chapter 6), somewhat ironically, we had to slow recruitment from this ‘hard-to-reach’ group due to therapists’ lack of capacity, creating a waiting list. Mindful that delays in accessing CaFI could reinforce negative perceptions of services resulting in the disengagement and withdrawal, we undertook the following actions:

• facilitated group supervision to better understand the factors contributing to a lack of capacity and how best we could support therapists to continue delivering CaFI

• recruited additional therapists from other Greater Manchester NHS trusts to deliver CaFI to service users on the waiting list

• extended the recruitment and intervention period to enable service users on the waiting list to receive CaFI

• extended recruitment to a neighbouring trust (GMW) to explore the feasibility of rolling CaFI out at an alternative site.

Six months into the intervention period, we recruited four additional lead therapists and four co-therapists to support the delivery of CaFI to people on the waiting list. The lead therapists comprised three clinical psychologists working in three different Greater Manchester NHS trusts (GMW, Pennine Care NHS Foundation Trust and Central Manchester University Hospitals NHS Foundation Trust) and one mental health nurse/clinical practice lead in a MHSCT rehab unit who had received training in advanced psychosocial interventions for psychosis. The four co-therapists comprised an assistant psychologist, two support workers and one postgraduate researcher (delivering FI to parents experiencing psychosis as part of doctoral study).

The second wave of therapists received copies of the manual and supporting materials. They also received training in using the manual from the research team. Owing to time and other resource constraints, they did not complete the Just Psychology and Meriden Family Programme training programmes. Instead, therapists were provided with copies of all training materials and listened to audio-recordings of the training sessions.

Recruitment

We successfully recruited 13 FSMs as a result of our extensive engagement and publicity strategies during study phases 1 and 2. Advertisement was conducted via the community launch events, local media (community radio, newspaper), distributing posters/flyers (see Appendix 18), and delivering presentations at local third-sector organisations and locations frequented by large numbers of African-Caribbean people, such as ‘Black-majority churches’. Recruitment materials provided contact details of the research team. Potential FSMs met with the research team for an informal interview to determine their suitability for the role and were fully briefed about the study. The RPM worked through the PIS (see Appendix 19) with the FSMs before obtaining informed consent to participate. Nine out of the 13 recruited FSMs took part in the feasibility study (see Chapter 6, Results for FSM sample characteristics).

Training content

To address the training needs of FSMs, we developed a bespoke training programme based on key components identified during phase 1 (see Box 9) and drew on expertise within the research and training teams.

Family support members completed a Disclosure and Barring Service and other relevant checks (e.g. MHSCT’s confidentiality agreement, occupational health), in line with NHS policies and procedures for working with service users at trust sites. FSMs received 1-day ‘cultural competency’ training delivered by Just Psychology. Key components of the training included developing awareness and understanding of:

• schizophrenia and psychosis, and specific issues affecting African-Caribbean people

• diversity in African-Caribbean cultures

• the impact of racism and discrimination on mental health

• mental health legislation, including The Equality Act (2010)132

• how to build relationships with family members

• how to build relationships with staff.

Family support members received an additional 2-hour training session facilitated by the research team (PI and RPM), which comprised:

• background/context of CaFI

• CaFI research protocol

• practical considerations relating to the FSM role

• expectations and skills/qualities for FSM role

• supervision and peer (FSM) support.

Supervision

As FSMs were essentially volunteers and included former service users, it was important that they were provided with strategies for accessing support and retaining appropriate boundaries. FSMs received monthly group supervision from the clinical supervisor (KB) to share their experiences and discuss any concerns, barriers or risk issues relating to supporting the service user through the intervention. FSMs also had the opportunity to contact or meet with the clinical supervisor independently between these sessions. During the initial CaFI session, therapists were required to agree on the boundaries and expectations of the FSM–service user relationship in collaboration with the FSM and the service user.

Cultural competency workshop

To increase cultural awareness within the trust, CaFI co-applicant and internationally leading expert on mental health and diversity, Professor Dinesh Bhugra, delivered a 2-hour ‘cultural competency workshop’ to health-care professionals working in the participating teams at MHSCT. The aim was to facilitate organisational change by increasing staff confidence in working effectively with service users from different cultural backgrounds. The event was also used as a vehicle to raise awareness of and promote recruitment for the CaFI study.

We originally planned to conduct three separate workshops within individual teams but this was impeded by the limited capacity of individual teams to host such events. Anecdotal feedback from trust staff suggested that facilitating one larger event with a keynote speaker would be more appropriate and would maximise attendance.

Staff participation

Key trust staff and service leads were invited to attend through targeted e-mails to ensure that the training was delivered to provide the greatest impact at MHSCT. Out of the 30 people who registered, 17 attended; we received two apologies for absences due to unforeseeable circumstances on the day. The remaining 11 people did not attend despite e-mail prompts leading up to the event asking delegates to give up their places to people on the waiting list if they were no longer able to attend. Attendees were three service managers, one consultant mental health nurse, two psychiatrists, two clinical psychologists, one OT, one assistant psychologist, five social workers, one Professor of Mental Health Nursing and one R&D staff member.

Meriden Family Programme training

Just Psychology cultural competency training

Research team training

Clinical teams cultural competency workshop

Method

Before the workshop, attendees were asked to rate four items from one (not very good) to 10 (excellent):

1. level of confidence in working effectively with people from cultural backgrounds different from their own

2. awareness and knowledge of cultural issues in mental health

3. ability to form therapeutic relationships with people from different cultural backgrounds

4. awareness of ‘cultural competence’ and how it applies to their work as mental health practitioners.

Respondents were also asked an open-ended question about any learning outcomes that they would like the seminar to cover.

Following the seminar, an evaluation form was administered that included the same four questions as the one that had been distributed before the event. The change in mean scores for self-reported cultural competence pre to post training is reported in the Table 3.

TABLE 3 - t-test for differences between health-care professionals’ self-reported cultural competence pre to post training

*p < 0.005, **p < 0.01.

Question	Before training (n = 18)	After training (n = 18)	Mean difference	SD	t-value
How confident do you currently feel about your ability to work effectively with people experiencing mental health problems whose cultural background is different from yours?	Mean = 6.31	Mean = 7.75	1.44	1.93	2.978**
How would you rate your current awareness and knowledge of issues relating to the impact of culture on mental health?	Mean = 6.19	Mean = 7.81	1.62	2.42	2.687*
How confident do you currently feel about your ability to build a therapeutic relationship with individuals with mental health problems whose background is dissimilar from yours?	Mean = 6.63	Mean = 7.75	1.12	1.93	2.334*
How would you rate your current awareness and knowledge of ‘cultural competence’ and how this applies to your work?	Mean = 5.81	Mean = 7.56	1.75	2.35	3.976**

The post-training evaluation form also included a feedback section that asked attendees to rate the seminar on a Likert scale from one (very poor) to five (very good), in terms of its content/information and presentation/delivery. Figure 6 shows the proportion of responses in relation to the content of the training and Figure 7 shows the proportion of responses in relation to the delivery of the training. Four additional open-response questions asked attendees:

1. what they liked about the training and what aspects of it were useful

2. what they liked least about the training and what improvements could be made

3. to provide suggestions for future training events

4. for any additional comments or feedback.

FIGURE 6.

Health-care professionals’ feedback in relation to the workshop content/information.

FIGURE 7.

Health-care professionals’ feedback in relation to the workshop presentation/delivery.

The responses to these open-ended questions have been collated and are presented in Table 3.

A paired samples t-test was conducted to allow comparison of the ratings from the pre- and post-workshop questionnaires. As detailed in Table 3, there was a significant difference pre to post training for each of the four items, which suggests that health-care professionals’ self-reported cultural competency improved following the workshop. Mean scores for attendees’ self-reported measure of cultural competence significantly improved for each of the four items, suggesting that the workshop was successful in increasing awareness and knowledge of the impact of culture on mental health and the application of cultural competence in mental health care, and improving staff members’ confidence in working effectively and building therapeutic relationships with people whose cultural background is dissimilar to their own.

Figure 6 shows that the majority of attendees rated the content of the training as either ‘good’ or ‘very good’, with none of the attendees rating the content lower than average. The mean response was 4.14 out of a possible 5, suggesting that the group as a whole thought that the content of the training was good.

Figure 7 demonstrates that the majority of responses in relation to the presentation and delivery of the training were ‘good’ to ‘very good’. The mean response across the group was 4.07 out of a possible 5, suggesting that the majority of the group were satisfied with the way in which the information was delivered.

In the open-ended questions regarding attendees’ views on the workshop, most reported that 2 hours was not long enough to cover such a large topic in a satisfactory level of detail, with some suggesting that future sessions addressing culture and mental health (rather than just ‘ethnic diversity or cultural competency’) would be beneficial. Positive feedback included the importance and relevance of the workshop content relating to cultural identities, explanatory models for mental illness and cultural awareness, the opportunity to learn from a world expert and the interactive nature of the seminar.

Aims and objectives

The CaFI feasibility study (phase 3) addressed the second of four research questions:

Is it feasible for culturally adapted FI to be delivered in hospital and community settings to African-Caribbean service users and their families?

Design

A feasibility cohort study incorporating a qualitative component.

Sample size

Over 9 months, we planned to recruit and consent a convenience sample of 30 participants via MHSCT and community referral. An audit of MHSCT data via the trust clinical information system (AMIGOS 3.0; Usable Systems, Dyfed, UK) at one time point (18 February 2015), indicated that there were 290 service users meeting our inclusion criteria. We estimated around 200 potential participants would be well enough to participate, of whom 150 would be eligible and 20% (n = 30) would opt in to the study. Thirty service users are sufficient to examine the feasibility of delivering the intervention across a range of service user and family types.

Participant inclusion/exclusion criteria

Participants and recruitment procedures

Service users

Service users were recruited via their care teams or self-referral. Recruitment at MHSCT was slower than anticipated and, therefore, we expanded recruitment to a second site, GMW (see Second wave of recruitment).

African-Caribbean people remain in inpatient services for longer than their White British counterparts,13,15 so implementation of CaFI in acute as well as community settings might improve engagement and outcome. Therefore, we recruited participants from acute wards, rehabilitation units and community settings to include service users at differing levels of acuity and chronicity, and assess the feasibility of delivering CaFI across different clinical environments.

Advertisement posters and flyers (see Appendix 24) were placed in MHSCT sites that were accessible to service users and in community locations. NIHR Clinical Research Network (CRN) clinical studies officers (CSOs) supported recruitment by helping to identify and recruit suitable participants. CSOs and RAs visited teams at CMHTs and inpatient services to present the study and inform clinical staff about the inclusion criteria. Recruitment packs, including the study PIS (see Appendix 21), were posted to service users who were well enough [following risk assessment from care co-ordinator (CC)/clinical team], had the capacity to consent and gave permission for their contact details to be handed to the research team. The CSO/RA followed this up with a telephone call (at least 24 hours later). Interested service users were invited to meet with the RA to receive further information about the study and ask any questions. During the meeting, service users were asked to self-ascribe their ethnicity (as this is often recorded incorrectly in case notes) and provide written informed consent. Consenting participants were invited to complete baseline assessments in the initial meeting or an additional meeting. Figure 8 shows the Consolidated Standards of Reporting Trials (CONSORT) flow diagram163 that details CaFI service user participant flow163 and the progress of service user participants through the study.

FIGURE 8.

The CONSORT flow diagram: CaFI service user participant flow. Reproduced from Edge et al. 158 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. The figure includes minor formatting changes to the original text.

Reproduced from Edge et al. 158 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. The figure includes minor formatting changes to the original text.

There were four ways in which service users were identified for referral into the CaFI study:

1. CRN face to face – CSOs were located at different NHS settings and spoke to service users and clinical staff about the CaFI study, alongside other studies they were recruiting to. They recorded names and contact details of service users who met the criteria and were willing to be approached by the research team for further information. This information was then passed to the RPM/RA.

2. CaFI research visit teams – RAs/CSOs regularly presented the CaFI study to clinical and management teams in various NHS settings. CCs approached the service users about the study and passed on the contact details of eligible service users who were willing to be approached to the RPM/RA.

3. E-mails to CCs based on electronic case notes – the trust recruitment facilitator/information technology manager screened the clinical information system (AMIGOS) and generated a list of CCs of those service users who met the study eligibility criteria. RAs/CSOs sent e-mails to CCs asking if they would approach the service users on their caseload to see if they would be happy to be contacted by the research team.

4. Direct contact from referrer – CCs heard about the study through adverts (via NHS staff intranet, daily mail, posters/flyers at trust sites), presentations at team meetings or ‘word of mouth’; and contacted the research team directly with names of interested service users.

Intervention

In phase 1, we designed the CaFI intervention comprising 10 sessions as follows (see Appendix 16 for description of manual components):

• sessions 1 and 2 – engagement and assessment

• sessions 3 and 4 – shared learning

• sessions 5 and 6 – communication

• sessions 7 and 8 – stress management, coping and problem-solving

• sessions 9 and 10 – staying well and maintaining gains.

Quantitative data collection

Data analysis

Quantitative data were analysed using Stata^® 14 (StataCorp LP, College Station, TX, USA). Data analysis followed a predetermined statistical analysis plan (see Appendix 25) drawn up by the trial statistician and agreed with the research team.

We present descriptive statistics on our primary outcome of recruitment, consent, demographics, adherence, missing or incomplete scales and attrition of participants, including an exploratory analysis of factors affecting adherence and attrition (using univariate associations with failure to complete).

We examined the characteristics of the various outcome measures to consider which might be appropriate in a future trial and estimated variability to inform sample size calculation.

The EQ-5D-5L scores were used to calculate a health utility index,190 commonly used in cost–utility analyses of definitive RCTs. This made its distribution of interest in understanding the scale’s suitability for a larger trial recruiting from this population. As a secondary analysis, the hypothesis that the intervention would improve health utility index over time in all participants was tested by comparing scores before and after the intervention. Given that the data were skewed and that there were theoretical, prima facie reasons that CaFI might work differently when service users worked with family members rather than with FSMs, the hypothesis was tested using t-tests, bootstrapped with 200 repetitions from separate strata for dyads with family members and those with FSMs. This analysis was performed for both service users and participants, without correction for multiple testing given its exploratory nature. 191

Relapse data were unavailable for definitive analysis, but readmission data from the trial participants and the two groups of matched controls were summarised to examine the proportions readmitted over follow-up; the number and length of readmissions; and the difference in these data between groups and within individuals between TP1 (before the start of intervention) and TP2 (after the start of admission). Each time period was defined as a ‘mirror image’ that is the duration of TP2 was the period from recruitment to data collection at the end of the trial and TP1 was defined as an identical duration before recruitment. As a series of secondary analyses, the number and duration of admissions during TP1 and TP2 were compared between groups and a survival analysis comparing time to first admission during TP2 between groups was conducted. These analyses tested the hypotheses that (1) CaFI would lead to a reduction in the number, total duration and hazard of admissions; and (2) these changes would be greater than any changes in the populations from which the matched samples were drawn. The comparison allowed for identification of trends in admission that were common to the intervention and control groups. Again, for such exploratory analyses, there was no correction for multiple testing. 191

Recruitment

Baseline characteristics

Feasibility of CaFI delivery

Of the 31 service users recruited into the study, 27 completed the baseline outcome measures and 26 started CaFI by attending at least one therapy session. Twenty-four family units completed all 10 therapy sessions.

Outcome measures for a future randomised controlled trial

We report on (1) data completeness, (2) variability, (3) distribution and (4) change in outcomes.

Relapse rates

Relapse measure

At the time of writing, data for the comprehensive assessment of relapse180 remain to be finalised. As not all relapse data were collected owing to the hospital merger, this work is ongoing. Data regarding relapse will be available and presented in future trial publications. For the report, relapse data will therefore be presented for the audit at MHSCT only. Not all relapse data were collected owing to the hospital merger. This work is ongoing. Data will be included in the main trial outcome paper (in preparation).

Hospital admissions

For all three groups (CaFI service users, matched Black and White British controls), the mean period of assessment before and after the intervention was 313 (SD 142) days. The number of inpatient days was skewed. Before intervention, the overall median stay across all groups was 0 (quartiles 0, 0; range 0–733) days. Afterwards, the overall median was also 0 (quartiles 0, 0; range 0–168) days; this did not differ significantly over time across groups (p > 0.05, Wilcoxon matched-pairs signed-rank test), despite a noticeable shortening of maximum admission length (Table 16).

TABLE 16 - Number of admissions before and after intervention and lengths of these periods by group

Group	Inpatient days before intervention, median (range)	Number of admissions before intervention			Inpatient days after intervention, median (range)	Number of admissions after intervention
		0	1	2		0	1	2
CaFI participants	0 (0–588)	22	4	1	0 (0–160)	23	3	1
White controls	0 (0–366)	24	2	1	0 (0–104)	23	4	0
Black controls	0 (0–733)	24	3	0	0 (0–168)	24	3	0

There were no significant differences between the groups in the number of admissions in the control period before the intervention started (p > 0.05, Fisher’s exact test) or in the length of inpatient stay (p > 0.05, Kruskal–Wallis test). Nor did time to relapse differ between the groups (p > 0.05, Cox regression model stratified by gender and controlling for age; Figure 9).

FIGURE 9.

Kaplan–Meier survival estimates. Survival time (days) without relapse before intervention across groups. BC, Black Caribbean; WB, White British.

There were no significant differences between the groups in the number of admissions in the period after intervention started (p > 0.05, Fisher’s exact test; see Table 16). This did not represent a signficant decrease in the number of admissions for the CaFI group (p > 0.05, Wilcoxon matched pairs signed-rank test) or the two control groups (p > 0.05 and p > 0.05). Nor did days in hospital differ signficantly across all groups (p > 0.05, Wilcoxon), between groups (p > 0.05, Kruskal–Wallis test) or over time for any of the groups (p > 0.05, p > 0.05, p > 0.05 for the CaFI group, White and Black controls, respectively, Wilcoxon test).

Time to admission after the intervention did not differ signficantly between groups (p > 0.05, Cox regression model stratified by gender and controlling for age). Controlling for length of survival in the previous period by adding this to the model (adjusting for differences between individuals, and hence groups, in propensity to be admitted) made almost no difference (p > 0.05 between groups).

Withdrawals/attrition from therapy

Of the 31 service users who consented to the study, five dropped out pre intervention, four pre baseline and the remaining one post baseline. Out of these, the research team lost contact with three, one reported not feeling well enough to take part and one did not feel able to commit to the study due to new work commitments.

Of the 26 service users and respective family members/FSMs who started the therapy, three service users dropped out during therapy and did not re-engage. Out of these, one service user disengaged after session 3 (but their two family members continued with the therapy) and two service users dropped out after session 9; one service user relapsed and one agreed but did not attend the final session. In addition, one family member dropped out after session 1 due to a family bereavement and two FSMs (one nominated and one recruited) dropped out at session 4 because they could not be contacted after session 3.

Post intervention, four service users dropped out. Two did so following relapse, one refused to complete assessments and one could not be contacted. One family member and one nominated FSM were lost post intervention, one did not complete the assessments because their relative had relapsed shortly after the intervention and the research team were unable to contact the nominated FSM after the service user had completed therapy. All seven recruited FSMs who finished therapy completed post-intervention assessments. Two staff members did not complete post-intervention assessment: one did not want to because the client had relapsed and they had not been in contact with them for a while; and the other staff member was unavailable because of illness.

Thirteen family units were not approached to complete 3-month follow-up assessments as a result of delays in therapy delivery (see Chapter 5, Therapist recruitment). Of the participants approached, one service user dropped out as they no longer wished to be contacted, one refused to complete assessments and two did not complete assessments owing to relapse. In addition, one nominated FSM did not complete follow-up assessments as they could not be contacted. All staff members and recruited FSMs who were approached completed the 3-month follow-up assessments.

Changes in family members/family support members during therapy

Six service users changed family members/FSMs during the study, but these changes were addressed early on in therapy. Two service users nominated their key workers to participate with them, but these key workers dropped out post baseline as they changed their place of work before the therapy started. One of these service users subsequently took part with a recruited FSM and the other took part with their CC. Two service users initially opted to take part with family members but then changed to take part with FSMs post baseline. One experienced a breakdown in their relationship with their family member before therapy started, so a FSM was recruited, who joined from session 3. The other family member withdrew owing to a family bereavement after session 1; there was then a suspension of therapy and the service user started therapy again from session 1 with a recruited FSM. Of the remaining two participants, one changed to a different recruited FSM from session 7 following a period of disengagement resulting from the service user’s alcohol misuse and the other service user changed from two recruited FSMs to a nominated FSM following a breakdown in therapy after session 3 (this service user used subsequently resumed therapy from session 1 with two new therapists).

Two other service users experienced a suspension in therapy and did not change family member/FSMs but changed therapists. One service user disengaged at session 5 and re-engaged at session 7 following a pause in therapy. The other disengaged after session 1 because he did not feel comfortable working with male therapists, and the family restarted therapy after being allocated female therapists.

Method

The CaFI fidelity measure is a modified version of the subscale of the Cognitive Therapy Scale for Psychosis,46 which has been adapted for this study to account for the presence of two therapists and the relatives. Seven items were used: agenda setting, feedback, understanding, interpersonal effectiveness, collaboration, homework, and quality of CBT techniques. The second subscale includes components that map directly on to the CaFI therapy manual, along with two additional items from the FIPAS:47 reducing criticism and conflict; and reducing overinvolvement. The third and final subscale comprised six items that rated the degree of cultural awareness or competencies of the therapists during the session. This subscale was based on the manual and existing cultural competency questionnaires and literature192–196 (see Appendix 26 for the CaFI fidelity measure).

Fidelity was assessed by independent ratings of 10% of semi-randomly selected sessions, ensuring equal spread across therapist pairs and session number. This was achieved by initially randomly choosing a recording for each therapist pair from the sessions remaining unsampled and randomly selecting a recording. We randomly sampled from all remaining recordings until we had reached the desired 10%. Treatment fidelity and quality were also monitored via discussion of audio-recordings of sessions in supervision. Every 6 weeks therapists also submitted a session to the clinical supervisor who rated the recording using the fidelity scale and gave feedback to the therapists.

Results

Overall, therapists scored well on part I of our scale, which reflected skills in CBT for psychosis (Table 17). Scores on the understanding, collaboration and interpersonal effectiveness items were particularly high, whereas feedback and homework items were lower.

Part II of the fidelity scale reflects the nature of topics covered within sessions, as opposed to the quality of delivery. All of the components of the manual were represented at least once, with the exception of three subcomponents (plans are put in place to reward and evaluate goals; goals are evaluated and rewarded when achieved; and help family to tolerate slow change within sessions). The independent rater also noted that it was not possible to rate the expressed emotion items on the content fidelity scale when family members were not present. Subcomponents related to communication and to helping the family formulate their own role in maintaining stress and the service user’s problems in a non-judgemental way seemed to be particularly well represented at least on the basis of the random selection of recordings rated (Table 18). Although, the independent rater noted that when family members were not present during sessions, the therapy was more akin to individual CBT than FI, and some aspects of family work during the sessions were not listed in the content part of the fidelity scale (Box 11).

Part III of the fidelity scale reflects cultural competence. At least half the sessions rated demonstrated evidence of aspects of cultural competence assessed. In fact, four out of six competencies assessed were evident in all, or nearly all, of the sessions rated (Table 19). The independent rater did, however, note that part III of the fidelity subscale was particularly difficult to rate. Without detailed information about the families, it was difficult to know whether cultural awareness or a cultural narrative should have been present but was missed, or if it was appropriately omitted.

The Barrowclough and Tarrier197 FI model clearly influenced the therapists’ practice. Non-psychologists had limited experience implementing psychological therapies with complex client groups, and so struggled in formulating this complexity and intervening in a less circumscribed idiosyncratic way. The clinical psychologists were more experienced in formulating and adapting to complexity. Although they clearly drew on the Barrowclough and Tarrier FI model,197 they also drew on other areas of expertise. For example, one lead therapist specialised in child and family work outside the study and another therapist was carrying out a more specialist course in cognitive analytic therapy. The independent rater also noted that therapists from non-psychological backgrounds tended to conceptualise psychosis in medical terms and used illness model language which did not necessarily facilitate discussion about other ways of thinking about mental health, such as including cultural appraisals and psychological factors.

Discussion of fidelity findings

Overall, fidelity assessment demonstrated that therapists were able to deliver therapy to protocol with good evidence of core skills in CBT for psychosis, as well as cultural competency and coverage of core components of the manual. A few exceptions may require increased emphasis in future training and supervision protocols, including opportunities for feedback, setting and/or reviewing homework, and reviewing and rewarding goals. The independent rater also highlighted some aspects of therapy that were evident in the recordings but were not listed in the second part of the fidelity scale, such as addressing problems not related to psychosis, managing communication outside the family and services, and understanding voices and ways of coping with these (see Box 11), which suggests that iterations of the measure may need to be more comprehensive. Expressed emotion items were not rated when the family were absent, which may also suggest that future iterations of the measure should include the clause ‘rate only if family member present’ prior to the expressed emotion items. Independent raters in future trials may benefit from more detailed information about family background and context to facilitate rating cultural competency subscales. Further consideration should be given to the role of FSMs and how to better utilise this resource within sessions.

Although we did not systematically assess therapists’ effects on the fidelity ratings because of the small number of therapist pairs, observations in supervision did suggest that therapists who had completed a doctorate in clinical psychology and were routinely providing therapy within other roles within the NHS, were more skilled in formulating and working with complex issues that presented in therapy. Observations by the independent rater also noted that non-psychologists presented a more medicalised concept of psychosis, which may partly reflect the predominance of this model within mental health services, but is nonetheless inconsistent with the ethos of the family therapy we aimed to deliver in the trial. Taken together, these findings highlight the benefits of the therapy being delivered by individuals with more specialised training in therapy or providing more intensive training and supervision to less-experienced staff.

Summary of findings

We successfully recruited our target of service users to CaFI, slightly exceeding our recruitment goal of 30. We recruited an additional participant because one had withdrawn before we ended the recruitment period and we had 30 spaces for therapy.

We also successfully allocated at least one family member or FSM to each service user. Half the service users who started therapy nominated a member of their family to join them in the CaFI intervention; around one-quarter (23%) nominated someone else known to them and one-quarter selected someone from the pool of recruited FSMs. One (4%) attended with both a family member and a nominated FSM. In a few cases, service users selected a relative or CC (nominated FSM) to take part with them, but they could not work with the service user because of a reported lack of interest or work commitments. There were a couple of cases where service users started the sessions with their chosen relative/FSM but certain circumstances (e.g. bereavement) meant that the relative/FSM dropped out of therapy. In both situations, service users were given the opportunity to work with a recruited FSM, which highlights the benefits of this approach as it enabled service users to receive CaFI who otherwise would not have access to the intervention.

As might be expected, the most successful method of identifying potential participants was face to face, with either the CRN CSO staff approaching service users or the CaFI researchers visiting clinical staff in their work setting; three-quarters of recruitment was done face to face with service users or clinical staff. Recruiting NHS service users can be a convoluted process as researchers must go through the service users’ CCs who have limited capacity to support research studies and refer service users on their caseload. In the present trial, this proved to be a lengthy process and led to delays in reaching those service users who were interested in the research or receiving complimentary therapy. Often RAs were required to wait for a couple of months before they could attend clinical team meetings and CCs would not respond to e-mails or return telephone calls. The CRN CSOs working in inpatient and rehab wards were, however, able to access service users face to face, which highlights the need for CRN support in mental health trials.

Most people (84%) who were identified proved to be eligible for the study. Reasons for ineligibility included lacking capacity, assessed as being ‘high risk’ and not being of African-Caribbean origin. NHS staff often incorrectly referred people of Black African ethnicity, which may highlight problems with the recruitment materials and language use (i.e. anecdotal feedback suggests that ‘Black Caribbean’ is less confusing than ‘African-Caribbean’, which could be mistaken for both Black African and Black Caribbean). It may also point to a lack of cultural understanding among clinical professionals about the diversity of Black cultures and the ethnic background of their clients. The research team have previously conducted audits at the host NHS trust (MHSCT) and found that ethnicity is often recorded incorrectly. The conversion rate from eligibility to consent was 42%, and the most common reasons for not providing consent were lack of interest, being too busy, or it being the wrong time. Compared with non-consenters, those who consented to the study were slightly older and more likely to be women.

In our study protocol,158 we planned to recruit from three types of setting: community settings, rehabilitation units and acute inpatient settings, with 10 services users in each setting. We successfully recruited from all three settings, but the spread across them was unequal: 21 were living in community settings (17 CMHTs, three EIS and one third sector), seven in rehabilitation units (including 24-hour staffed supported housing and hospital units) and three in acute inpatient wards. This may be an accurate reflection of the distribution of people meeting the criteria in these different settings. However, there were high numbers of referrals via the CRN from acute inpatient settings, presumably because the CSOs were located in these settings and could approach service users face to face and monitor new referrals. We found these acute settings more difficult to recruit from, because people tended to go in and out of them quite quickly, and some service users had moved on by the time we contacted them for the consent visit. Others were too ill to participate or lacked capacity to provide informed consent. In such cases, RAs/CSOs would approach the service user once the CC confirmed that they were well enough. It may therefore be helpful to gauge interest from service users receiving acute care, but to engage them in therapy only when deemed appropriate and when they have the capacity to participate.

Of the service users who entered the study, two-thirds were male and all were of African-Caribbean origin; the mean age was 43 years. Reflecting national census data,14 most were born in the UK (79%), with around one-third being of mixed ethnic background, one of the fastest growing ethnic categories. Most were single (81%) and over half lived alone (56%), reflecting previous reports of the impact of schizophrenia on social networks. 198 This finding also perhaps underscores the need to identify FSMs to work alongside service users who may be socially isolated. All but three service users had schizophrenia spectrum diagnoses; these people were recruited from EIS and, therefore, had not yet received a diagnosis (but this was confirmed by a psychiatrist to be non-affective psychosis).

Of the 31 service users who consented to take part in the study, 27 completed the baseline measures and 26 started CaFI. Among the 26 family units who started therapy, there was a high completion rate: 24 (92.31%) completed treatment, with completion defined as attendance at all 10 sessions by the service user, the family member or both. The mean number of sessions attended by family units was 7.74 (SD 3.81) out of 10 sessions. The number of family units who completed CaFI within the expected therapy window of 20 weeks was 12 out of 24 (50%) and the mean time to complete therapy was 23.27 weeks.

The therapy was delivered by therapist pairs, of which three were led by psychologists and four were led by CCs. Completion rates were the same for psychologists (12/13) and non-psychologists (12/13). The time taken to complete the therapy was longer for the non-psychologists (29.62 weeks) than the psychologists (16.92 weeks). These findings are supported by literature on the implementation of FI, which suggests that therapists need to have ring-fenced time rather than taking on therapy as part of their care co-ordination role. 33,161

The outcome measures are suitable for use in a future clinical trial, but they may need some adjustment for skewness. We were successful in collecting outcome measures from therapists and for most of the service users and family members who completed each stage of the trial. We report the variability of the measures for use in estimating sample size for a future trial.

Recommendations for the design of a future trial

• The identification of service users to approach for the trial took more time than we had anticipated. Although face-to-face approaches are more labour intensive, a future trial should concentrate on these methods of recruitment, as they were the most successful in this feasibility trial. This is perhaps because of previous adverse relationships and limited experience or knowledge of therapy in this group.

• Consent rates were fairly high in community settings, but gaining consent was much more difficult in acute settings as a result of high turnover, acute mental health state and lack of capacity. A future trial involving acute and rehabilitation settings should identify greater numbers of service users to allow for this drop-off. Recruitment efforts at acute sites should involve gauging interest of eligible participants and following them up when they are deemed well enough to engage in therapy.

• We were able to recruit families, nominated FSMs and a pool of recruited FSMs. All three types of families were taken up by service users, demonstrating the feasibility of delivering CaFI with FSMs. The findings from the fidelity study suggest that further work is needed to determine whether or not this represents a different intervention. Nevertheless, it is important to note that half of the service users who started therapy would not have been able to participate without FSMs, suggesting a role that FSMs may have for other socially isolated groups beyond CaFI (e.g. the forensic population).

• Most family units completed CaFI, which suggests that it was acceptable, and this is reinforced by the acceptability findings that will be discussed in Chapter 7. However, only half completed treatment within the therapy window of 20 weeks and, in particular, therapy delivered by non-psychologists took a longer time, suggesting that in a future trial we may need to consider additional training and supervision if non-psychologists are to deliver the intervention. We need to take greater measures to ensure that staff members have ring-fenced time to provide therapy, which involves them taking a reduced caseload of care co-ordination clients. Although this ring-fenced time was agreed by managers at the outset as part of the present study, these boundaries were not always adhered to. This was partly because therapy was only a small part of each of the initial lead therapists’ role, and all therapists were still trying to engage a relatively large caseload of other clients.

• Although reasonable levels of fidelity were achieved, qualitative feedback from supervision suggested that, compared with less experienced therapists, those who were more experienced in delivering therapy as part of their routine job roles demonstrated greater skill in case formulation and working with the complexity presented by some of the families in the study. This suggests that future studies need to recruit experienced therapists or provide more intensive training and supervision to less experienced staff. Although these training requirements have implications for delivery in the NHS, it is noteworthy that the psychologists in the study were all relatively newly qualified (< 3 years post qualification) and had worked at no higher than band 7 in their other posts.

• The methods of data collection adopted in this feasibility trial achieved high rates of completion at baseline and post intervention. We also achieved a high proportion of responses at 3 months post intervention, although the number of participants who reached that point before the trial ended was small (due to delays in therapy delivery) and, as such, not all participants could be approached for 3-month follow-up assessments. This suggests that the outcome measures were acceptable and feasible to collect from service users, families, FSMs and key workers.

• One of the anticipated outcomes of CaFI is an improvement in the relationship between the service user and their key worker, and this should be measured as one of the outcomes of a future RCT. However, we identified that 3 out of the 31 services users in this feasibility study changed their key worker during therapy and, therefore, the post-intervention and follow-up assessments were completed by a different key worker. Further thought is needed about how this discrepancy can be assessed in future trials. Additionally, some items on the WAI were not deemed acceptable by service users and key workers, which led to missing total scores. Future trials should identify whether or not these items should be included and how to manage missing data for single items.

Procedures and materials

Service users and family members/FSMs completed feedback sheets (see Appendix 27) to capture immediate responses and to assess the acceptability of each CaFI session and of the intervention overall. Feedback sheets included six statements, four of which were positively worded:

1. ‘I learned something new today’.

2. ‘I know where to get more information’.

3. ‘I have a better relationship with my relative’.

4. ‘I am more able to say what my needs are’.

To check engagement with the measure, two negatively worded items were included:

1. ‘I am more worried about my ability to cope’.

2. ‘The session was not useful’.

Two additional items sought participants’ views on the length of sessions and their feelings about attending the next session.

Data collection

Feedback sheets were distributed by therapists. They were completed by each individual, placed in sealed envelopes, labelled with identification numbers and returned to the therapists, who passed them to the RPM/RA for analysis. This was intended to maximise data capture and reassure participants about confidentiality.

Data analysis

Using descriptive statistics, data were analysed separately for services users and family members/FSMs, overall ratings (across all sessions), by therapist type, by clinical setting and by session number.

Results

Procedures and materials

To measure the quality of the therapeutic relationship,175 the WAI173 (see Chapter 6, Outcome measures for a future randomised controlled trial) was completed by all session attendees at the end of the third therapy session.

Lead therapists and co-therapists individually completed separate key worker versions of the WAI in relation to the service user and each family member/FSM. Each service user and family member/FSM completed the client version of the WAI in relation to the therapist dyad (i.e. both lead and co-therapist).

Data collection

The WAIs were completed by each individual and placed in sealed envelopes labelled with identification numbers. Therapists then passed them to the RPM/RA for analysis (upholding confidentiality).

Results

Participants

To gain deeper insight into the acceptability of the intervention to service users, families, FSMs and therapists, we aimed to conduct qualitative interviews with all study participants. A sample of key workers from acute, rehabilitation and community settings was also purposively selected for interview. This approach enabled maximum variation in the sample in terms of profession, gender, clinical setting, retention in CaFI (i.e. those who completed the sessions and those who withdrew) and familial relationship type (family member/FSM).

Procedures

As qualitative follow-up interviews were ethically approved as part of the feasibility study, participants’ consent was obtained as part of this study before baseline assessments were carried out (see Chapter 6). The therapists informed the RPM/RA when the final sessions were planned so that post-intervention assessments could be scheduled in advance and process consent could be obtained via telephone.

Consenting participants were offered the choice of completing interviews during the post-intervention assessment or at an alternative date within the 3-month follow-up period. Service user, family and FSM participants received £10 for taking part in the interview.

All interview data were stored and managed in accordance with the University of Manchester’s Data Protection Policy and Management Plan and MHSCT’s R&D policy.

Materials

We developed study-specific interview schedules (see Appendix 28 for service user example) tailored to explore each group’s perspectives on different aspects of the study, including:

• perceptions of the need and benefits of CaFI

• usefulness, cultural specificity and accessibility of CaFI and supporting materials

• content and delivery of CaFI sessions

• perceived barriers to/facilitators of implementation

• views and experiences of training/supervision

• views and experiences on the role of FSMs

• participating in research versus therapy.

Using predominantly open-ended questions in a semistructured interview format allowed us to explore aspects of the intervention that participants particularly liked or disliked and areas where improvements should be made. Interviews were conducted by the RPM/RA.

Data analysis

Interviews were digitally recorded, transcribed, checked for accuracy and analysed using framework analysis. 42 Thematic analysis had originally been proposed. However, as the data were intended to address a priori topics, a deductive approach was more appropriate. 202 The RPM and RA read and re-read the transcripts (familiarisation) before completing coding. To ensure data quality, a 10% sample was reviewed by the PI and discrepancies were resolved through discussion.

A coding framework was developed by clustering similar codes into preliminary themes and subthemes. These were reviewed by the wider research team and an independent qualitative methodologist. This framework was then applied across the entire data set, charting, indexing and annotating themes. This resulted in a refined (conceptual) framework, illustrated by particularly relevant quotes, which was examined by the research team and an independent qualitative expert for goodness of fit and the final theoretical framework agreed. Mapping the data onto the framework facilitated synthesis, interpretation and ‘auditability’. 128 Transparency of these processes attest to the ‘trustworthiness’ of findings. 203

NVivo 10 software (QSR International, Warrington, UK) was used to support data management and analysis. To preserve participants’ anonymity, illustrative quotations are presented using truncated study identification numbers.

Results

Developing CaFI

We have provided evidence on how to successfully culturally adapt FI for African-Caribbean people diagnosed with schizophrenia and related disorders (research question 1) using co-production approaches. This is important because although a number of previous studies have developed cultural adaptation frameworks,69,136 none has been explicit about the process.

First, our systematic review207 identified key components of adapting psychological interventions for minority groups. We used these to develop our cultural adaptation framework comprising:

• concepts

• cultural norms and practices

• culturally relevant content

• communication and language

• context

• cultural competence of practitioners.

Second, in key stakeholder focus groups, these concepts were applied systematically to the content and delivery of the extant FI34 model that we sought to culturally adapt.

Third, the final model was agreed in a consensus conference comprising ‘experts’ by experience and profession. As in previous studies,61,136 respondents did not suggest changes to the core components of the intervention. Rather, they highlighted additional factors to improve the cultural specificity of its content, acceptability and the feasibility of its delivery. Experts also identified the training needs of CaFI therapists and FSMs together with suggestions for how these might be met.

In developing CaFI, the ‘psychoeducation’ component of the intervention underwent the greatest change from current FI. The most significant change in this regard was adopting an explicit ‘shared learning’ ethos of delivery (vs. ‘psychoeducation’). ‘Shared Learning’ goes beyond good clinical practice, acknowledging therapists’ need to acquire/develop culturally appropriate knowledge and understanding,159 as well as families’ learning about schizophrenia and psychoses. This approach was advocated by stakeholders explicitly to address the power imbalance in therapy and to reduce social distance and hierarchy between therapists and families. Other major adaptations included adding specific communication and advocacy sessions to help families understand their rights and to improve interaction with services. These adaptations were regarded as especially pertinent for fostering therapeutic engagement with African-Caribbean people, given consistently reported delayed engagement or non-engagement with services. 30

The therapy manual and supporting materials were designed to raise therapists’ awareness of what it means to be a person of African-Caribbean origin living with a schizophrenia diagnosis in the UK. The manual therefore includes information about the location, customs and cultural diversity of the Caribbean islands (‘there’s no such thing as Caribbean culture’), as, during focus groups, health professionals identified this as a gap in their knowledge. The manual also supported exploration of issues that many African-Caribbean people associate with onset of psychoses, including experiences of everyday discrimination and institutional racism. 23,208

Issues of race and racism were integral to many African-Caribbean service users’ and families’ illness models. According to them, and to health professionals in our study, racism often remained ‘the elephant in the room’ (an obvious problem or risk no one wants/feels able to discuss) during therapy and encounters with health-care professionals more generally. This is because African-Caribbean people fear that raising racism might be either regarded as evidence of paranoia or interpreted as attacking health-care staff. From staff’s perspective, they reported a lack of skill in addressing this sensitive and potentially personally challenging issue. Understanding the relationship between African-Caribbean people’s illness models and their experiences therefore provides an important context for deeper understanding of contextual factors and establishing therapeutic alliances with people who, understandably, may be anxious and/or appear avoidant in therapy.

Can new interventions in family intervention be delivered in today’s NHS?

An important element of any feasibility process is understanding if and how new interventions can be delivered in the services for which they are designed. Psychological therapies have become well evidenced and NICE recommended in recent years in mental health broadly and in schizophrenia and psychosis specifically. 30,58 Notwithstanding the evidence of its efficacy and cost-effectiveness, FI provision within mental health services is inconsistent. 161,162 This is partly because FI is perceived as being labour intensive and, therefore, expensive despite being contrary to the evidence, suggesting failure to take into account the financial, social and psychological cost of the burden of care experienced by families. 209

In the CaFI study, we encountered challenges in recruiting suitably qualified and experienced FI therapists (Agenda for Change band 7) as recommended by NICE11 in the host trust. We subsequently recruited band 6 (advanced practitioner) non-psychologists ‘with experience of FI’. Having recruited CCs as therapists, we found that they were delivering CaFI alongside their routine roles and responsibilities without agreed protected time. This often meant prioritising clinical responsibilities over delivering the intervention, causing delays in delivering sessions and the ironic situation whereby our ‘hard-to-reach’ group of service users and families were being placed on a waiting list to receive therapy. As a result, we employed newly qualified band 7 clinical psychologists from other Greater Manchester trusts on a sessional basis to fill the gap in local provision. The fact that we were able to retain service users, families and FSMs despite these delays bears testament to the high levels of engagement and commitment to receiving the intervention that we had achieved.

Although exacerbated by the organisational and financial issues affecting our host trust, our findings highlight previous concerns about the ongoing lack of suitably qualified therapists to deliver FI in the NHS,161 despite NICE guidance. 30 The fact that we were able to recruit staff from neighbouring trusts does indicate that this may a feature of service configuration versus actual numbers of available therapists. In the absence of clear information about the availability of FI therapists across the country, we advocate that future trials consider alternative approaches to lack of trained FI therapists in the NHS such as using clinical psychology and psychiatry trainees to deliver psychosocial interventions. This proposal would have the additional benefit of building NHS capacity by creating a broader pool of available FI therapists.

Our experience of delivering CaFI raises concerns about the implementation of new and, indeed, existing, interventions in the NHS. We acknowledge that the financial constraints and service pressures we encountered within our host NHS trust, resulting in its dissolution and merger with a neighbouring organisation, were extreme. Although NICE guidance30 is likely to influence future practice, current evidence suggests that barriers to implementing psychological interventions are widespread and apparently entrenched across the NHS. 210 It is noteworthy that we encountered additional barriers such as missing data and inaccuracies in recording information, including ethnicity and assessment of relapse. Given that the NHS has a statutory Public Sector Equality Duty to provide services equitably,132 it is difficult to understand why these data were not routinely collected, especially given policies aimed at ‘DRE [Delivering Race Equality] in mental health’. 206 The NHS equality and diversity mapping exercise (2017) should provide more up-to-date information about the organisational capacity to deliver against the various mandated equality and diversity standards across England. We also advocate process evaluation and inclusion of implementation science in future trials to evaluate the extent to which the challenges we faced are being addressed by NICE guidance and related commissioning. Additionally, as some of the data inaccuracies related to mislabelling African service users as Caribbean, recruitment into future trials including both African and Caribbeans might be less problematic in terms of data accuracy.

The implications of increasing financial constraints and service pressures for our study and future studies in this domain are various if such interventions are to be taken forward based on successful cost-effectiveness and clinical effectiveness evidence. Not only do such interventions require impetus and support from local commissioning, local services and manpower also need forward planning to ensure the availability of therapists of sufficient seniority to supervise more junior clinicians should such an intervention be taken forward with successful cost-effectiveness and clinical effectiveness evidence. In other words, new interventions must be commissioned and specifically planned with specialist training and clear career pathway development considered from the outset. This means that investment in FI cultural adaptation and in future full-scale trials needs to be considered in the longer-term plans of those commissioning and delivering local mental health services.

Implementing and evaluating CaFI

We achieved our primary outcome of recruiting to target. Of 74 eligible service users, 31 (42%) consented (exceeding our original expectations that 1 : 3 would participate). We also achieved a high retention rate. Twenty-four of the 26 recruited family units that commenced CaFI (92%) completed therapy despite significant organisational service barriers that resulted in service users and families being on a waiting list for some time. This is a major achievement in this group, whose engagement with services has been poor historically and who are under-represented in research.

Our success is at least partly attributable to novel ways of engaging with this community. These include hosting events in ‘Black-majority churches’ and community centres, publishing articles about Black mental health in local newspapers and instigating discussions about mental health via ‘phone-ins’ on local radio. Going into this community and asking them to identify their research priorities and how to address them enabled us to co-produce a solutions-focused research.

It is noteworthy that, despite decades of previous research identifying the lack of access to psychological therapy and family disruption in this community, CaFI marks the first attempt to develop a culturally appropriate intervention. Although the fact that the PI was a member of the African-Caribbean community might have facilitated access, this alone cannot account for the high levels of engagement (especially as the remainder of the research team and all but two of the therapists were White).

All service users, families and therapists found CaFI acceptable and would recommend it to others. Service users and family members were especially positive about the ‘shared learning’ ethos of delivery and opportunities to acquire/enhance communication and advocacy skills. They also commented positively on the therapists’ personal qualities and self-disclosure. Willingness to share their own personal experiences was important for trust building and normalisation of experiences. This is especially important for members of this ethnic group given previously reported lack of discussion about mental illness among community members due to misconceptions, stigma and cultural taboos about ‘talking your business’. 35,36

Only one FSM dissented from the overwhelmingly positive evaluation, indicating that, from the their perspective, CaFI had not met the needs of one service user. According to the FSM, the service user, who had deep-rooted fears of services due to experiences of racism, perceived the therapy content to be ‘White’. Specifically, the FSM did not believe that CaFI addressed the issue of racism sufficiently. Although this was not reflected in qualitative interviews with other participants (including the service user in question) in the acceptability study (see Chapter 7), it raises an important issue about whether this FSM’s perception of CaFI’s as ‘White’ related to its content or to the fact it was delivered by White therapists.

Our exploration of ‘ethnic matching’ of therapists and families reflect previously reported ambivalence about if and to what extent shared ethnicity between therapists and clients affects the nature of therapeutic engagement. 211 Although conceding the potential value of ‘ethnic matching’ for some families, participants concluded that this was impracticable in a NHS in which the majority of therapists are White or Asian. Moreover, endorsing findings from a meta-analysis which reported almost no benefit to treatment outcomes from racial/ethnic matching of clients with therapists,211 they suggested that the most important factor in therapeutic alliance was establishing trust as the basis of open communication.

Culturally adapted Family Intervention therapists reported that they valued the opportunity to gain in-depth knowledge about and experience of working with members of an ethnic group known to have complex needs. This enabled them to utilise both advanced and newly acquired skills. Although those who received the full training package (all non-psychologists) reported significant increase in cultural awareness and confidence (see Chapter 5), this was not reflected in the trial or acceptability data. Psychologists, although more recently qualified than non-psychologists, were more likely to deliver CaFI within the therapy window and were more positively rated by family members. This may reflect clinical psychologists’ greater familiarity with the model from which CaFI was derived and more advanced training such as cognitive analytic therapy, which afforded greater flexibility and skills to work with complex client groups. However, lack of protected therapy time and competing clinical priorities undoubtedly contributed to non-psychologists’ self-reports of sometimes insufficient time to reflect, plan and prepare for sessions.

It is also noteworthy that the clinician who independently rated CaFI sessions (see Chapter 6) noted that non-psychologists tended to conceptualise psychosis using ‘illness model language’, which did not facilitate discussion about cultural appraisals or alternative models of mental illness. This is important because this and previous studies36,212 indicate that, in common with other BME groups, African-Caribbean people’s conceptualisations often differ from those of White Westerners, who make up the majority of NHS therapists. Cultural competence and ‘psychological mindedness’ are therefore important considerations for delivering CaFI and other interventions, suggesting that capacity building is warranted if such interventions are to be delivered by non-psychologists.

Across all groups, the most frequently mentioned benefits derived from CaFI were improved understanding of schizophrenia and psychosis and communication between service users and health-care professionals, as well as with their families (see Chapter 7). Some CCs also reported improved communication with families. For example, one CC reported that a service user’s partner had begun to engage with her for the first time and was demonstrably more supportive and less dismissive of his illness. This is important given the well documented lack of engagement and adverse relationships between mental health services and African-Caribbean people. We know that this leads to increased carer burden, more family conflict (often resulting in families involving the police) and service access via adverse care pathways. 8,16

Delayed access is also costly for the NHS. The mean inpatient stay of African-Caribbean people is around 2.5 times longer than that of their White British contemporaries. The former also are more frequently hospitalised and more likely to be released on costly CTOs. 11 Improved communication between service users, their families and health-care professionals might facilitate earlier access to care, with an associated reduction in costs. Our findings suggest that evaluation of the clinical effectiveness and cost-effectiveness of culturally specific interventions, such as CaFI, in fully powered trials is warranted.

An important finding from our acceptability study was participants’ view that CaFI should be rolled out across the NHS and made available to all ethnic groups versus limiting its perceived benefits to African-Caribbean people. Participants further suggested that, as it was not feasible to implement different culturally adapted versions of FI for each ethnic/cultural group in the UK, a culturally adaptable form should be developed. This marks an interesting and important departure from the increasing number of culturally adapted psychological interventions. 58,61,213

Although culturally adaptable approaches were more often suggested by African-Caribbean service users and health-care professionals, they were also endorsed by other participants. Given recent changes in the UK population’s ethnic make-up,214 NICE guidance on implementing FI30 and the changing commissioning landscape, a culturally adaptable FI is appealing. However, the service barriers we experienced, principally a service virtually denuded of FI expertise, would need to be addressed for the benefits of CaFI and other forms of family work to be fully realised.

Study outputs

We have produced a series of new resources that can fill a gap for new practice and capacity building in NHS:

• therapy manual

• supporting materials215

• therapist training manual

• FSM training

• fidelity measure

• KAP measure216

• CaKAP measure216

• framework for cultural adaptation (one paper in preparation and a published related systematic review207).

Peer-reviewed publications

Edge D, Degnan A, Cotterill S, Berry K, Drake R, Baker J, et al. Culturally-adapted Family Intervention (CaFI) for African-Caribbeans diagnosed with schizophrenia and their families: a feasibility study protocol of implementation and acceptability. Pilot Feasibility Stud 2016;2:39.

Degnan A, Baker S, Edge D, Nottidge W, Noke M, Press CJ, et al. The nature and efficacy of culturally-adapted psychosocial interventions for schizophrenia: a systematic review and meta-analysis. Psychol Med 2017:1–14.

Edge D, Grey P. An assets-based approach to co-producing Culturally-adapted Family Intervention (CaFI) with African-Caribbeans diagnosed with schizophrenia and their families. Ethn Dis 2018; in press.

Peer-reviewed conference contributions

Edge D, Stephens A, Thomas Y. Overcoming Challenges: Innovative Solutions in Public Involvement in Research. NIHR Research Design Service North West Patient and Public Involvement (and Engagement) Conference, Manchester, 2016.

Edge D, Degnan A. Service Users, Carers and Healthcare Professionals’ Perceptions and Experiences of Mental Health Services for African-Caribbean People Diagnosed with Psychosis: A Qualitative Study. Division of Clinical Psychology Annual Conference, Liverpool, 2017.

Invited conference contributions

Edge D. Culturally-adapting Family Intervention (CaFI) for African-Caribbeans Diagnosed with Schizophrenia: An Assets-Based Approach to Co-Production. World Psychiatric Conference International Congress, Cape Town, South Africa, 2016.

Edge D, Thomas Y. Cultural Adaptation, Implementation and Evaluation of Family Intervention for African-Caribbean Service Users with Schizophrenia in Secondary Care. NIHR/Medicines and Healthcare products Regulatory Agency, Nottingham, 2014.

Search strategy

1. exp schizophrenia/ or exp psychosis/

2. (psychotic or schizo* or psychosis or psychoses).sh.ti.ab.hw.id [subject heading, title, abstract, heading word, key concepts]

3. ((chronic* or sever*) adj5 mental* adj5 (ill* or disorder*)). sh.ti.ab.hw.id.

4. or/1-3

5. exp ethnology/ or exp culture (Anthropological) / or exp racial and ethnic groups/ or exp racial and ethnic differences/ or exp cross-cultural differences/ exp sociocultural factors/ or exp cultural sensitivity/ or exp acculturation/ or exp minority groups

6. (ethnic* or ethnolog* or cultur* or acculturation or rac* or minorit* or transcultur* or sociocultur*).sh.ti.ab.hw.id.

7. ((cultur* adj3 (identity or cross or specific or sensiti* or relevant or adapt* or competen* or divers*)).sh.ti.ab.hw.id.

8. ((ethnic or racial) adj3 (identity or group or minorit* or difference or variation or divers*)). sh.ti.ab.hw.id.

9. or/5-8

10. exp cross-cultural treatment/ or exp psychosocial rehabilitation/ or exp mental health services/ or exp psychotherapy/ or exp behaviour therapy/ or exp sociotherapy

11. ((psychological or psychosocial or psychiat* or clinical) adj5 (intervention or therap* or rehabilitation or treatment or care)).sh.ti.ab.hw.id.

12. ((cognitive or behav* or famil* or systemic or social* or education*) adj5 (intervention or therap* or rehabilitation or treatment or training or skill*)).sh.ti.ab.hw.id.

13. ((cognitive or behav*) adj5 (remediat*).sh.ti.ab.hw.id.

14. ((evidence based or empirically supported) adj5 (intervention or therap* or treatment)). sh.ti.ab.hw.id.

15. or/10-14

16. exp clinical trials/ or exp treatment effectiveness evaluation/

17. exp experimental controls

18. (controlled or clinical) adj3 (trial). sh.ti.ab.hw.id.

19. (random* or control* or trial or condition or assigned or group). sh.ti.ab.hw.id.

20. or/ 16-19

21. 4 and 9 and 15 and 20

Search strategy

1. exp schizophrenia/ or exp psychotic disorders/

2. (psychotic or schizo* or psychosis or psychoses).ab.hw.kf.ti.kw [abstract, subject heading word, keyword heading word, title, keyword heading]

3. ((chronic* or sever*) adj5 mental* adj5 (ill* or disorder*)).ab.hw.kf.ti.kw

4. or/1-3

5. exp culture/ or exp ethnology/ or exp acculturation/ or exp cross-cultural comparison/ or exp cultural characteristics/ or exp cultural diversity/ or exp ethnic groups/ or minority groups

6. (ethnic* or ethnolog* or cultur* or accultur* or rac* or minorit* or transcultur* or sociocultur*).ab.hw.kf.ti.kw

7. (cultur* adj3 (identity or cross or specific or sensiti* or relevant or adapt* or competen* or divers*)). ab.hw.kf.ti.kw

8. ((ethnic or racial) adj3 (identity or group* or minorit* or difference or variation or divers*)). ab.hw.kf.ti.kw

9. or/5-8

10. exp rehabilitation/ or exp mental health services/ or exp psychotherapy/ or exp behaviour therapy

11. ((psychological or psychosocial or psychiat* or clinical) adj5 (intervention or therap* or rehabilitation or treatment or care)). ab.hw.kf.ti.kw

12. ((cognitive or behav* or famil* or systemic or social* or education*) adj5 (intervention or therap* or rehabilitation or treatment or training or skill*)). ab.hw.kf.ti.kw

13. ((cognitive or behav*) adj5 (remediat*). ab.hw.kf.ti.kw

14. ((evidence based or empirically supported) adj5 (intervention or therap* or treatment)). ab.hw.kf.ti.kw

15. or/10-14

16. exp clinical trial/ or exp controlled clinical trial/ or exp randomized controlled trial

17. exp random allocation/ or exp double-blind method/ or exp single blind method/ or exp control groups

18. (controlled or clinical) adj3 (trial). ab.hw.kf.ti.kw

19. (random* or control* or trial or condition or assigned or group). ab.hw.kf.ti.kw

20. exp feasibility studies/ exp pilot projects/ exp intervention studies

21. or/16-20

22. 4 and 9 and 15 and 21

Search strategy

1. exp schizophrenia/ or exp psychosis/

2. (psychotic or schizo$ or psychoses or psychosis).ti.hw.ab.kw.sh [title, heading words, abstract, key word, subject headings]

3. ((chronic$ or sever$) adj5 mental$ adj5 (ill$ or disorder$)).ti.hw.ab.kw.sh [title, heading words, abstract, key word, subject headings]

4. or/1-3

5. exp ethnology/ or exp ethnic group/ or exp cultural factor/ or exp minority group/ or exp cultural anthropology/ exp ethnic and racial groups/ exp cultural competence

6. (ethnic$ or ethnolog$ or cultur$ or accultur$ or rac$ or minorit$ or transcultur$ or sociocultur$).ti.hw.ab.kw.sh

7. (cultur$ adj3 (identity or cross or specific or sensiti$ or relevant or adapt$ or competen$ or divers$)).ti.hw.ab.kw.sh

8. ((ethnic or racial) adj3 (identity or group$ or minorit$ or difference or variation or divers$)).ti.hw.ab.kw.sh

9. or/5-9

10. exp psychiatric treatment/ or exp psychotherapy/ or exp sociotherapy/ or exp mental health services/ or exp psychosocial rehabilitation/ or exp behaviour therapy

11. ((psychological or psychosocial or psychiat$ or clinical) adj5 (intervention or therap$ or rehabilitation or treatment or care)). ti.hw.ab.kw.sh

12. ((cognitive or behav$ or famil$ or systemic or social$ or education$) adj5 (intervention or therap$ or rehabilitation or treatment or training or skill$)). ti.hw.ab.kw.sh

13. ((cognitive or behav$) adj5 (remediat$). ti.hw.ab.kw.sh

14. (evidence based or empirically supported) adj5 (intervention or therap$ or treatment). ti.hw.ab.kw.sh

15. or/10-14

16. exp clinical trials (topic)/ or exp controlled clinical trial/ or exp randomized controlled trial

17. exp randomisation/ or exp control group

18. (controlled or clinical) adj3 (trial). ti.hw.ab.kw.sh

19. (random$ or control$ or trial or condition or assigned or group).ti.ab

20. exp intervention study/ exp pilot study/ exp feasibility study

21. or/ 16-20

22. 4 and 9 and 15 and 21

Search strategy

1. (MH “Schizophrenia+”) OR (MH “Psychotic Disorders+”)

2. TX=(psychotic OR schizo* OR psychosis OR psychoses)

3. TX=((chronic* OR sever*) N5 mental* N5 (ill* OR disorder*))

4. OR/1-3

5. (MH “Culture+”) OR (MM “Acculturation”) OR (MM “Cultural Diversity”) OR (MM “Ethnic Groups”) OR (MM “Ethnology”) OR (MM “Minority Groups”) OR (MM “Cultural Competence”)

6. TX=(ethnic* OR ethnolog* OR cultur* OR accultur* OR rac* OR minorit* OR transcultur* ORsociocultur*)

7. TX=(cultur* N3 (identity OR cross OR specific OR sensiti* OR relevant OR adapt* OR competen* OR divers*))

8. TX=((ethnic OR racial) N3 (identity OR group* OR minorit* OR difference OR variation OR divers*))

9. OR/5-8

10. (MH “Rehabilitation, Psychosocial+”) OR (MH “Mental Health Services+”) OR (MH “Psychotherapy+”) OR (MH “Behavior Therapy+”)

11. TX= ((psychological OR psychosocial OR psychiat* OR clinical) N5 (intervention OR therap* OR rehabilitation OR treatment OR care))

12. TX=((cognitive OR behav* OR famil* OR systemic OR social* OR education*)N5 (intervention OR therap* OR rehabilitation OR treatment OR training OR skill*))

13. TX=((cognitive OR behav*) N5 (remediat*))

14. TX=((“evidence based” OR “empirically supported”) N5 (intervention OR therap* OR treatment))

15. OR/10-14

16. (MH “Clinical Trials+”) OR (MM “Double-Blind Studies”) OR (MM “Intervention Trials”) OR (MM “Triple-Blind Studies”) OR (MM “Therapeutic Trials”) OR (MM “Single-Blind Studies”) OR (MM “Randomized Controlled Trials”)

17. (MM “Random Assignment”) OR (MM “Control Group”)

18. TX=((controlled OR clinical) N3 (trial))

19. TX=(random* OR control* OR trial OR condition OR assigned OR group)

20. TX= (“intervention study” OR “pilot study” OR “feasibility study”) OR MH “Feasibility Study”

21. OR/16-20

22. 4 and 9 and 15 and 21